NCT01862198CompletedPhase 4
Pilot Study on the Usefulness of Endoscopic Ultrasound-guided Biliary Drainage With a Newly Designed Hybrid Metallic Stent
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Inje University
- Enrollment
- 27
- Locations
- 4
- Primary Endpoint
- The stent patency rate
Study Overview
Brief Summary
The purpose of this study is to investigate the feasibility and safety of endoscopic ultrasound-guided biliary drainage with a newly designed hybrid metallic stent.
Detailed Description
Endoscopic ultrasound-guided biliary drainage with a fully covered metallic stent was a safe and effective method in patients with malignant biliary obstructions and had a comparatively long patency duration. Nevertheless, the significant rate of distal stent migration cannot be ignored, suggesting the need for a newly designed metallic stent for endoscopic ultrasound-guided biliary drainage.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age > 20 years
- •The presence of an unresectable malignant biliary obstruction
- •Failed conventional ERCP stenting
Exclusion Criteria
- •Age < 20 years
- •An inability to sedate the patient due to advanced heart or pulmonary diseases
- •A lack of informed consent
Outcomes
Primary Outcomes
The stent patency rate
Time Frame: Up to 48 weeks
Secondary Outcomes
- Patients' survival rate(Up to 48 weeks)
- Complication rate related to the hybrid stents(Up to 48 weeks)
Investigators
Tea Jun Song
Assistant professor
Inje University
Study Sites (4)
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